Sandrena Gel

Sandrena gel is a hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. Sandrena is a gel applied directly on dry and clean skin. Sandrena can be used for continuous or cyclical treatment. In patients with an intact uterus, it is recommended to combine Sandrena with an adequate dose of progestagen, for adequate duration for at least 12-14 consecutive days per month. Sandrena comes in sachets of 0.5 mg estradiol in 0.5 g of gel, or in sachets of 1 mg estradiol in 1g of gel. Each pack of Sandrena 0.5 mg gel contains only 0.5 g sachets and each pack of Sandrena 1 mg gel contains only 1 g sachets. When the gel is applied on to the skin the oestrogen is absorbed through the skin in to the blood circulation, increasing oestrogen levels and therefore reducing menopausal symptoms.

Sandrena Gel is used for relief of symptoms occurring after menopause. During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Sandrena alleviates these symptoms after menopause.

Please Note: Sandrena is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Do not use a hormonal contraceptive while using HRT.

The Sandrena dose is applied once daily on the skin of the lower trunk of the right or left thigh, on alternate days. The application surface should be 1-2 times the size of a hand. Sandrena should not be applied on the breasts, on the face or irritated skin. After application the gel should be allowed to dry for a few minutes and the application site should not be washed within 1 hour. Contact of the gel with eyes should be avoided. Hands should be washed after application.

The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the selection of the initial dose can be based on the severity of the your symptoms. Depending on the clinical response, the dosage can be readjusted after 2-3 cycles individually from 0.5 g to 1.5 g per day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.

If you have forgotten to apply one dose, the forgotten dose is to be applied as soon as possible if the dose is not more than 12 hours late. If the dose is more than 12 hours late, the dose should be forgotten and continued as normal. Forgetting a dose may increase the likelihood of break-through bleeding and spotting.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using the gel and see your doctor straight away, if you notice any of the following serious side effects:

• your blood pressure rises
• your skin or the whites of your eyes go yellow (jaundice)
• you suddenly have migraine-type headaches (see section 2)
• you have signs of a blood clot

The following diseases are reported more often in women using HRT compared to women not using HRT:

• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65.

During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment.

Other side effects

Common (may affect up to 1 in 10 people):

• itching of the skin, rash, pain, increased sweating, swollen feet and lower legs
• breasts become tender or painful
• increase or decrease in your weight
• – headache, dizziness
• tummy pains, feeling sick or being sick, flatulence
• bleeding or spotting, menstrual disorder
• depression, nervousness, lethargy
• hot flushes.

The list above isn’t exhaustive. If you experience serious side effects or side effects lasting longer than 3 months then you should consult your doctor immediately.

Make sure you read the patient information leaflet for a full list of side effects, cautions and contraindications. You should only take HRT once you have understood all the warnings and precautions as HRT may increase your chances of getting certain cancers or cardiovascular disease. If you are concerned discuss this with your doctor or The Family Chemist clinician.

Do not use Sandrena:

• if you have or have ever had breast cancer, or if you are suspected of having it
• if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• if you have any unexplained vaginal bleeding
• if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• if you have or have ever had a liver disease and your liver function tests have not returned to normal
• if you have a rare blood problem called “porphyria” which is passed down in families (inherited)
• if you are allergic to estradiol or any of the other ingredients of this medicine Sandrena

If any of the above conditions appear for the first time while using Sandrena, stop using it at once and consult your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before using Sandrena. Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Sandrena. If so, you should see your doctor more often for checkups:

• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
• hereditary angioedema.

Stop using Sandrena and see a doctor immediately If you notice any of the following when taking HRT:

• any of the conditions mentioned in the “Do not use Sandrena” section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty in breathing

• https://www.medicines.org.uk/emc/files/pil.1048.pdf
• https://www.womens-health-concern.org/
• https://patient.info/medicine/oestrogen-and-progestogen-for-hrt
• https://www.nhs.uk/conditions/menopause/
• https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/